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Burning Rock and Boehringer Ingelheim Achieved a Master Service Agreement in Oncology Companion Diagnostics

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Burning Rock Biotech has signed a Master Service Agreement (MSA) with Boehringer Ingelheim in the field of oncology companion diagnostics. The partnership aims to advance clinical trials for Boehringer Ingelheim's MDM2-p53 antagonist, brigimadlin, and develop companion diagnostic products in China. Brigimadlin has received approval for its Phase II clinical trial, offering new treatment options for patients with MDM2-amplified, TP53 wild-type cancers. Burning Rock will provide support for the research and development of brigimadlin and companion diagnostic assays.
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GUANGZHOU, China, Oct. 30, 2023 (GLOBE NEWSWIRE) -- Burning Rock Biotech Limited (NASDAQ: BNR and LSE: BNR, the “Company” or “Burning Rock”) is pleased to announce that the Company and Boehringer Ingelheim officially have signed the Master Service Agreement (MSA) in the field of oncology companion diagnostics. This agreement aims to provide Chinese patients with safer, more efficient, and precise treatment options and diagnostic methods, thereby promoting innovation and development in cancer treatment. This partnership will primarily focus on advancing the clinical trials related to Boehringer Ingelheim's MDM2-p53 antagonist, brigimadlin (BI 907828), and the development of companion diagnostic products in China.

Brigimadlin is a novel small-molecule drug developed by Boehringer Ingelheim as a MDM2-p53 antagonist. Recently, brigimadlin received approval from the China National Medical Products Administration (NMPA) for its Phase II clinical trial, known as Brightline-2, targeting locally advanced or metastatic MDM2-amplified, TP53 wild-type solid tumors. It offers new treatment options for patients with MDM2-amplified, TP53 wild-type cancers, such as Biliary Tract Carcinoma (BTC), and opens up a “pan-tumor” treatment approach targeting the MDM2-p53 axis. Previous Phase I studies demonstrated anti-tumor activity for brigimadlin across various solid tumors, with particularly promising clinical efficacy observed in BTC patients.

With the formal approval of the Brightline-2 clinical trial, the safety and efficacy of brigimadlin will undergo further validation. Burning Rock will leverage its dual-center, internationally accredited laboratory, a global companion diagnostics registration pipeline, a comprehensive biomarker development solution for drug research, and its extensive experience in clinical projects and companion diagnostics development and submissions, providing comprehensive support for the research and development of the innovative drug brigimadlin and the development and validation of companion diagnostic assays, offering new hope for patients with hard-to-treat and rare cancers in China.

Mr. Yusheng Han, Founder and CEO of Burning Rock, expressed, “We are delighted to establish a deep collaboration in companion diagnostics with Boehringer Ingelheim. Burning Rock has a comprehensive layout and supports companion diagnostics development with a global perspective for pharmaceutical companies. We believe that by integrating the resources and expertise of both parties in the field of oncology diagnosis and treatment, this collaboration will set a standardized and high-quality benchmark for the co-development of companion diagnostics for new anti-cancer drugs. We look forward to achieving more significant breakthroughs in this collaboration and providing more precise treatment options for Chinese cancer patients.”

About Burning Rock
Burning Rock Biotech Limited (NASDAQ: BNR and LSE: BNR), whose mission is to guard life via science, focuses on the application of next generation sequencing (NGS) technology in the field of precision oncology. Its business consists of i) NGS-based therapy selection testing for late-stage cancer patients, and ii) cancer early detection, which has moved beyond proof-of-concept R&D into the clinical validation stage.

For more information about Burning Rock, please visit: www.brbiotech.com.

Enquiries:
Contact: IR@brbiotech.com


FAQ

What is the Master Service Agreement (MSA) between Burning Rock Biotech and Boehringer Ingelheim?

The MSA is an agreement that establishes a partnership between Burning Rock Biotech and Boehringer Ingelheim in the field of oncology companion diagnostics.

What is brigimadlin and what is its purpose?

Brigimadlin is a novel small-molecule drug developed by Boehringer Ingelheim as a MDM2-p53 antagonist. It offers new treatment options for patients with MDM2-amplified, TP53 wild-type cancers.

What is the Phase II clinical trial for brigimadlin?

The Phase II clinical trial, known as Brightline-2, targets locally advanced or metastatic MDM2-amplified, TP53 wild-type solid tumors.

What support will Burning Rock provide in this partnership?

Burning Rock will leverage its laboratory, companion diagnostics registration pipeline, biomarker development solution, and clinical project experience to support the research and development of brigimadlin and companion diagnostic assays.

What are the expected benefits of this collaboration?

The collaboration aims to provide Chinese patients with safer, more efficient, and precise treatment options and diagnostic methods, promoting innovation and development in cancer treatment.

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